drugset / Trial / NCT07523737

Pomalidomide, Anti-PD-1 Antibody Combined With Selinexor (PPS) in Relapsed/Refractory Primary Central Nervous System Diffuse Large B-Cell Lymphoma

NCT07523737

Phase 2 Recruiting 43 enrolled Beijing Tongren Hospital
NaSingle-groupOpen-labelTreatment

Summary

Primary central nervous system diffuse large B-cell lymphoma (PCNSL-DLBCL) is a highly aggressive malignancy accounting for over 80% of primary CNS lymphomas, with an annual incidence of 0.4-0.6 per 100,000 people globally and a rising trend in immunocompetent patients. First-line high-dose methotrexate-based chemotherapy causes severe toxicities and nearly 50% of patients relapse within 1-2 years, developing relapsed/refractory (R/R) disease. Treatment options for R/R PCNSL are scarce, with low response rates, median survival of only 3-6 months, and 5-year survival below 5%. The blood-brain barrier and tumor heterogeneity further worsen outcomes. This prospective, multicenter, single-arm phase II study evaluates the efficacy and safety of pomalidomide, PD-1 inhibitor, and selinexor (PPS) in R/R PCNSL, aiming to provide a new effective treatment.

Timeline

Start
2026-04-01
Primary completion
2028-03-31
Completion
2028-08-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Pomalidomide Other / unclassified 4 mg
Subject Selinexor Other / unclassified 60 mg
Subject Tislelizumab Monoclonal antibody 200 mg